Outlook Therapeutics · ONS-5010 · Aug 2025 – Jun 2026
Why do Outlook's filings give different dates for the FDA's letters?
The letters are signed August 27 and December 30, 2025. Some filings give August 28 or December 31, the days the press releases went out; one gives “December 2026”.
EphemerisX Research · Published · 10 source documents · 1 min read
Short answer
The FDA's signature pages are dated August 27 and December 30, 2025. Outlook's filings use those dates in places, and elsewhere use August 28 and December 31, 2025, which are the dates of the company's press releases about the letters; December 31 was also the goal date for the second review. A June 2026 release refers to a “December 2026” letter.
What the evidence shows
The letters' signature pages: 08/27/2025 01:00:37 PM
FDA · Aug 27, 2025 · p. 5 and 12/30/2025 01:26:55 PM
FDA · Dec 30, 2025 · p. 5.
The first letter. The 10-K gives both dates: received a subsequent CRL on August 27, 2025
10-K · Dec 19, 2025, and, in another risk factor, received a CRL on August 28, 2025
10-K · Dec 19, 2025. The press release went out the next day: On August 28, 2025
8-K · Sep 2, 2025, the company issued a press release announcing that the U.S. Food and Drug Administration issued a complete response letter
8-K · Sep 2, 2025. The September 8-K refers to the complete response letter (CRL) dated August 27, 2025
8-K · Sep 29, 2025.
The second letter. The review's goal date: received a PDUFA goal date of December 31, 2025 from the FDA
10-K · Dec 19, 2025. The press release: On December 31, 2025
8-K · Jan 2, 2026, the company issued a press release announcing that the U.S. Food and Drug Administration issued a complete response letter
8-K · Jan 2, 2026. The February 11, 2026 filing gives two dates: its cover page refers to the complete response letter (CRL) dated December 31, 2025
8-K · Feb 11, 2026, its press release to a Complete Response Letter (CRL) dated December 30, 2025
8-K · Feb 11, 2026.
The June 1, 2026 release: Outlook Therapeutics successfully appealed the December 2026 Complete Response Letter
8-K · Jun 1, 2026, a date later than the release itself. The April 21, 2026 release refers to the December 30, 2025 Complete Response Letter
8-K · Apr 21, 2026.
Follow the thread
- What did the FDA's August 2025 letter object to?Signed 08/27/2025
- What did Outlook say came out of its September 2025 meeting with the FDA?“Dated August 27, 2025”
- How did evidence the FDA said did not alter its conclusion come to establish substantial evidence?The June 2026 release
This investigation connects to
- What happens after a second FDA Complete Response Letter?Cross-investigation · Divergent outcome · with Aldeyra Therapeutics, CorMedix, Replimune, Verrica Pharmaceuticals
- How did two programs move forward after repeat FDA letters without running a new trial?Cross-investigation · Comparable evidence · with Replimune
- What is a Class 1 or Class 2 resubmission, and how did each play out in these records?Cross-investigation · Regulatory pathway · with Aldeyra Therapeutics, CorMedix, Replimune
- When is one trial enough? How the FDA weighed the evidence in three programsCross-investigation · Comparable evidence · with Aldeyra Therapeutics, Replimune
The documents, by date
The passages quoted
Outlook Therapeutics Form 8-K, filed September 2, 2025
On August 28, 2025, Outlook Therapeutics, Inc (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration issued a complete response letter to the Company’s biologics license application for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.Open at the source →
Outlook Therapeutics Form 8-K, filed September 29, 2025
today announced that it has completed the Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. Based on the discussion with the FDA, Outlook Therapeutics expects to resubmit its BLA before the end of calendar year 2025, after reviewing the agency’s feedback and meeting minutes.Open at the source →
Outlook Therapeutics Form 10-K, filed December 19, 2025
Upon receipt of the full month 3 efficacy and safety results for NORSE EIGHT, we resubmitted the BLA application for ONS-5010/LYTENAVA on February 27, 2025 and received a CRL on August 28, 2025.Open at the source →
Outlook Therapeutics Form 10-K, filed December 19, 2025
we resubmitted the BLA application for ONS-5010/LYTENAVA on February 27, 2025, and received a subsequent CRL on August 27, 2025. Following a September 2025 Type A meeting with the FDA, we resubmitted the ONS-5010/LYTENAVA BLA on November 3, 2025 and received a PDUFA goal date of December 31, 2025 from the FDA.Open at the source →
Outlook Therapeutics Form 8-K, filed January 2, 2026
On December 31, 2025, Outlook Therapeutics, Inc (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration issued a complete response letter to the Company’s biologics license application for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.Open at the source →
Outlook Therapeutics Form 8-K, filed February 11, 2026
today announced that it has submitted a Type A meeting request to the U.S. Food and Drug Administration (FDA) following receipt of a Complete Response Letter (CRL) dated December 30, 2025, regarding the Company’s Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).Open at the source →
Outlook Therapeutics Form 8-K, filed February 11, 2026
On February 11, 2026, Outlook Therapeutics, Inc (the “Company”) issued a press release announcing that it has requested a Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated December 31, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.Open at the source →
Outlook Therapeutics Form 8-K, filed April 21, 2026
today announced that it has completed its Federal Dispute Resolution meeting w ith the Office of New Drugs at the U.S. Food and Drug Administration (FDA). The meeting was conducted as part of the Company’s ongoing efforts to seek alignment with the FDA regarding the regulatory pathway for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) and as a follow-up to its recent Type A meeting with the Division of Ophthalmology and Office of Specialty Medicine regarding the December 30, 2025 Complete Response Letter (CRL) for the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degenerationOpen at the source →
Outlook Therapeutics Form 8-K, filed June 1, 2026
As previously announced, Outlook Therapeutics successfully appealed the December 2026 Complete Response Letter (CRL) related to the ONS-5010 Biologics License Application reviewed by the FDA. In their decision, the FDA Office of New Drugs concluded that substantial evidence of effectiveness has been established for LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD), therefore additional trials are not required.Open at the source →